REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE

K020308 · Ssl America'S, Inc. · KGO · Apr 3, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020308
• Device Name: REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE
• Applicant: Ssl America'S, Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Apr 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

The Biogel Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove is a disposable device made of synthetic material and is intended for use in hospitals and other health care facilities during invasive or non-invasive procedures for the protection of operating room personnel and patients, from microbial migration and surgical wounds from contamination.

Device Story

Disposable synthetic polyisoprene surgical glove; used in hospitals and healthcare facilities by operating room personnel. Provides barrier protection against microbial migration and contamination during invasive or non-invasive procedures. Device is sterile and powder-free; available in sizes 5.5 through 9.0.

Clinical Evidence

Bench testing only. Gloves tested per ASTM D3577-00 for sterility, freedom from holes, physical properties, and dimensions. Tested per ASTM D6124 to confirm powder-free status. Biocompatibility testing confirmed non-irritating and non-sensitizing properties.

Technological Characteristics

Material: Synthetic polyisoprene. Form factor: Disposable surgical glove, sizes 5.5-9.0. Sterilization: Sterile. Standards: Meets ASTM D3577-00 (physical properties, sterility, dimensions) and ASTM D6124 (powder-free).

Indications for Use

Indicated for use by hospital and healthcare personnel during invasive or non-invasive procedures to protect patients and staff from microbial migration and contamination of surgical wounds.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Biogel® Neotech II Surgical Gloves (K000421)

Submission Summary (Full Text)

{0}------------------------------------------------

k) New Device Submission – Pl Glove

# PART VIII. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In response to the requirements addressed by the Safe Medical Devices Act (SMDA) of 1990, a summary follows with the safety and effectiveness information upon which the substantial equivalence determination is based.

< 020308

# APR 0 3 2002

# SUMMARY OF SAFETY AND EFFECTIVENESS FOR BIOGEL® SKINSENSE™ POLYISOPRENE SURGICAL GLOVES

#### Submitter Information 1.

SSL Americas, Inc. 3585 Engineering Drive, Suite 200 Norcross, Georgia 30092 Contact Person: Joyce Ning Telephone No. 770-582-2152

#### Device Name 2.

Classification Name: Non-Latex, Synthetic Surgical Glove Biogel® Skinsense™ Sterile, Powder-Free, Proprietary Name: Synthetic Polyisoprene Surgical Glove

#### Predicate Device 3.

Primary: Biogel® Neotch II Surgical Gloves (K000421)

#### Description of the Device 4.

The device in this 510(k) submission is intended for the Biogel Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove (Classification number 79KGO). The Biogel Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove is a disposable device made from Non-Latex synthetic rubber material, polvisoprene. Glove size is available from size 5.5 through 9.0 in a half size increment.

{1}------------------------------------------------

#### 5. Indications for Use

The Biogel® Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove is a disposable device made of synthetic material and is intended for use in hospitals and other health care facilities during invasive or non-invasive procedures for the protection of operating room personnel and patients, from microbial migration and surgical wounds from contamination.

### Description of Safety and Substantial Equivalence 6.

The Biogel Skinscnsc™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Gloves are substantially equivalent to the Neotech II Powder-Free Synthetic Surgical Glove submitted and cleared under 510(k) under K000421. The only major difference is the use of synthetic polyisoprene instead of neoprenc polymer with its variations in the formulations. The results of the safety, effectiveness, and performance testing of the this proposed polyisoprene glove are detailed in this 510(k) submission and are summarized as follows:

- The gloves meet all ASTM D3577-00 requirements for sterility, 1. freedom from holes, physical properties, and physical dimensions.
- The gloves have been tested and shown to be non-irritating 2. and non-sensitizing under test conditions when evaluated in accordance with internationally recognized test methods.
- The gloves have been tested per ASTM D6124 and exceed the 3. requirements to demonstrate "powder-free" in nature.

The results enclosed in this submission have demonstrated that the Biogel Skinsense, Powder-Free, Synthetic, Polyisoprene Surgical Glove is safe and effective for its intended use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of what appears to be an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Joyce Ning Vice President, Regulatory Affairs SSL America's Incorporated 3585 Engineering Drive, Suite 200 P.O. Box 926090 Norcross, Georgia 30092-9214

APR 0 3 2002

Re: K020308

Trade/Device Name: Regent® Biogel® Skinsense™ Sterile, Powder-Free Regulation Number: 878.4460 Regulation Name: Surgeon's Gloves Regulatory Class: I Product Code: KGO Dated: January 28, 2002 Received: January 29, 2002

Dear Ms. Ning:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements

{3}------------------------------------------------

### Page 2 - Ms. Ning

of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally 1 edelar statues and regisments, including, but not limited to: registration Tou must comply with an the Piseling (21 CFR Part 801); good manufacturing practice and ifsing (21 CFR Part 807), idoling (21 cm ms (QS) regulation (21 CFR Part 820); and if requirences as set form in the quarty ajon control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section This letter will and w you to began india finding of substantial equivalence of your device to 510(K) prematics notification. - vice results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 II you desire specific ad novel 10 for in vitro diagnostic devices), please contact the and additionally 21 CFR Part 80911638. Additionally, for questions on the promotion and Office of Comphiance wee, please contact the Office of Compliance at [phone]. advertising or your working entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under noutheation (210) it it it it is of the Division of Small Manufacturers, International and the Act may be obtained from and a sumber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely you

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

{4}------------------------------------------------

510(k) New Device Submission - PI Glove

-Americas, Inc

# PART V. INDICATIONS FOR USE STATEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . .

3.0

### Indications for Use Statement

| Applicant: | SSL-Americas, Inc. |
|---------------------------|------------------------------------------------------------------------|
| 510(k) Number (if known): | K020308 |
| Device Name: | Regent Biogel ^® Skinsense ^™ Sterile, Powder-Free |

Synthetic Polyisoprene Surgeon's Glove### Indications for Use:

The Biogel Skinsense™ Sterile, Powder-Free, Synthetic Polyisoprene Surgical Glove is a disposable device made of synthetic material and is intended for use in hospitals and other health care facilities during invasive or non-invasive procedures for the protection of operating room personnel and patients, from microbial migration and surgical wounds from contamination.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use OI

Chin S. Cin

on Sign-Off) of Dental, Infection Control, Coneral Hospital Devices ter Blumber

9